Hi All
Just now stumbled onto this news piece on MRI contrasting agents
vis-a-vis patient health. Since, it is seldom that NMR/MRI technique is
associated with any occupational hazard of notable significance thus
far, this article caught my attention and I thought our community will
be curious as well to take a peek. Per our policy of not linking the
article, I am doing a C & P here. Due apologies in advance, if you feel
underwhelmed about the topic after the first few lines. If so, feel free
to delete the mail at once, I won't mind :-). Now....get prepared.....to
be scared ! (Halloween is round the corner).
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FDA warns of deadly side effect with imaging drugs
WASHINGTON – Federal health regulators are warning doctors that a class
of injectable drugs used in MRI medical imaging scans can cause a rare
and sometimes fatal condition in patients with kidney disease.
The Food and Drug Administration said Thursday it is adding its
strongest warning label to imaging agents that contain the chemical
gadolinium, highlighting the risks when used in patients with kidney
problems.
"These label changes are intended to help ensure these drugs are used
appropriately," the FDA said in a posting to its website. The warning
language will appear in a bolded box at the top of the drugs' labels.
The agency said in a statement that use of the drugs can lead to a rare
syndrome that causes hardening of the skin and tissue growth along
joints, eyes and internal organs. The ailment, which is sometimes fatal,
is called nephrogenic fibrosing dermopathy and has been reported in
patients with weakened kidney function.
There is no known treatment for the condition, though kidney transplant
appears to slow disease and even reverse it in some cases.
Known as contrast agents, the products are used to improve clarity in
medical scans of the heart and other internal organs. The FDA has
approved seven such agents since 1988.
While the nephrogenic syndrome has been reported with all seven drugs,
the FDA said three have greater risks than the others: Bayer
Healthcare's Magnevist, General Electric Healthcare's Omniscan and
Covidien's Optimark. The FDA label stresses that these drugs should not
be used in patients with kidney disease.
An agency spokeswoman said those three drugs are "chemically more
unstable" than the others in the class and "thus more likely to release
gadolinium."
Gadolinium is a metal with distinctive magnetic properties that increase
its visibility during MRI scans. It is known to be toxic to the liver.
The four other drugs are Prohance and Multihance from Brocco Diagnostics
Inc., Bayer's Eovist and Ablavar from Lantheus Medical Imaging.
The new FDA labels for all seven drugs instruct physicians to screen
patients for kidney disease before administering the agents. Doctors
should also order lab tests for patients who may be at increased risk of
reduced kidney function. The FDA said there haven't been any reports of
the syndrome in patients with normal kidney function.
There are two non-gadolinium-based imaging agents on the market, though
the FDA has approved them only for liver scans.
GE Healthcare said in a statement that the FDA's labeling reinforces
physician guidelines that already stress the importance of screening for
patients with kidney problems.
The company said MRI contrast agents "continue to be a valuable
diagnostic tool with a proven safety record for the overwhelming
majority of patients to whom they are prescribed."
Bayer said it will cooperate with regulators and "will make periodic
safety reports to the FDA and other regulators.
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*_______________________________
Rajan K Paranji, Ph.D.
*NMR Facility Manager
Department of Chemistry
Room 65, Bagley Hall
University of Washington
*Seattle, WA 98195*
*ph: 206 685 2581 pager:206 680 3779
fax: 206 685 8665
email: paranji_at_chem.washington.edu
___________________________________*
Received on Fri Sep 10 2010 - 08:09:59 MST